Theory of Mind in Children With DCD (TOM_DCD)

December 13, 2023 updated by: VakgroepRevalidatiewetenschappen, University Ghent

The aim of the study is to investigate theory of mind (ToM) in children with developmental coordination disorder (DCD). Dutch-speaking children, who are living in Flanders or The Netherlands (because comparisons will be made with Flemish and Dutch norms), will be included. In addition, children should be six until twelve years old with a DCD diagnosis confirmed by a multidisciplinary team (including a doctor).

During the test moment, ToM will be tested by ToM test-R and the motor skills by MABC-2. Beside, the ToM test-R will be filmed, but the child's face not shown. The parent/legal guardian will be asked to complete five online questionnaires (demographic and developmental questionnaire, CVO, SRS-2, SDQ and ToMBC), this can be completed in advance at home or at the test moment (researchers provide a laptop).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Ghent, Belgium
        • Recruiting
        • Universiteit Gent - Vakgroep revalidatiewetenschappen
        • Contact:
          • Lynn Bar-On

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age of child: from six to 12 years old
  • Confirmed diagnosis of DCD by a multidisciplinary team (including a physician)
  • Child lives in Flanders or the Netherlands
  • Child has Dutch as the mother tongue

Exclusion Criteria:

  • Diagnosis of autism spectrum disorder (ASD)
  • Blood related siblings of the child
  • Parent/legal guardian does not have an adequate level of Dutch
  • (IQ lower than 70) OR (no IQ information and child attends special education type 1 (mild intellectual disability) or type 2 (moderate to severe mental disability))

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Children with DCD
Behavioral: Assessment
  • Observations using two valid, observational instruments (MABC-2 and ToM test-R) that each child completes once at random.
  • A demographic and developmental questionnaire is completed once by the parent/guardian at recruitment.
  • Standardized questionnaires (Coordination Questionnaire For Parents (CVO), Social Responsiveness Scale second edition (SRS-2), Strengths and Difficulties Questionnaire (SDQ) and Theory of Mind Behavior Checklist (ToMBC)) are also questioned once to parent/guardian for data collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Theory of Mind
Time Frame: 2 hours
Measured with ToM test-R andTheory of Mind Behavior Checklist (ToMBC)
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 27, 2023

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2023-0329

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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